A Long Term Study of GK530G in Subjects With Acne Vulgaris

Galderma

Status and phase

Completed

Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: GK530G

Study type

Interventional

Funder types

Industry

Identifiers

NCT01910064

RDT.07.SPR.27125

Details and patient eligibility

About

This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.

Enrollment

436 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women at the age of 12 or older at the Screening visit.
Those with clinical diagnosis of acne vulgaris with more than 20 non-inflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion criteria

Those with more than two nodular acne lesions or any cyst.
Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment